Dapoxetine

Dapoxetine

Parámetro Especificaciones
Nombre del producto Dapoxetine
Número CAS 119356-77-3
Fórmula molecular C21H23NO
Peso molecular 305.41 g/mol
Apariencia Polvo cristalino de color blanco a blanquecino
Ensayo (HPLC) ≥99,01 TP3T
Solubilidad Soluble in methanol, ethanol; slightly soluble in water
Paquete 25 kg net weight in fiber drums, two polyethylene inner liners

Dapoxetine Structure

Sinónimos: Dapoxetine hydrochloride, (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine, LY210448, Priligy

Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) developed specifically for the treatment of premature ejaculation (PE). Unlike other SSRIs, dapoxetine has a rapid onset and short half-life, making it suitable for on-demand dosing. It is the first oral medication approved for PE in several countries and has gained significant attention in the pharmaceutical market.

Dapoxetine is synthesized through a multi-step chemical process, yielding a highly pure active pharmaceutical ingredient (API). It is available as the hydrochloride salt, which enhances its solubility and stability. The compound is typically manufactured under cGMP conditions to ensure consistent quality and compliance with pharmacopeial standards.

Descripción general y composición del producto

Dapoxetine is a chiral molecule with the (S)-configuration at the stereogenic center. It acts by inhibiting the reuptake of serotonin, thereby increasing serotonin levels in the synaptic cleft and delaying ejaculation. The hydrochloride salt is the predominant form used in commercial products due to its favorable physicochemical properties.

The API is characterized by high purity, typically ≥99.0% as determined by HPLC, and low levels of organic impurities. It is a white to off-white crystalline powder, freely soluble in methanol and ethanol, and slightly soluble in water.

Applications & Product Lines

  • Pharmaceutical formulations: Dapoxetine is formulated into immediate-release tablets for the treatment of premature ejaculation.
  • Research and development: Used as a reference standard in analytical laboratories and for studying serotonin reuptake inhibition.
  • Generic drug manufacturing: API for generic versions of dapoxetine hydrochloride tablets.
  • Contract manufacturing: Supplied to CDMOs for incorporation into finished dosage forms.

Quality Control Standards

Test Item Especificaciones
Identificación IR spectrum complies with reference standard
Pérdida por secado ≤0,51 TP3T
Metales pesados ≤20 ppm
Organic Impurities Any individual ≤0.1%; total ≤0.5%
Límites microbianos Total aerobic microbial count ≤1000 CFU/g; yeast and mold ≤100 CFU/g; absence of E. coli

Bulk Packaging & Supply

  • Embalaje: 25 kg fiber drums with two polyethylene inner liners
  • Cantidad mínima de pedido: 1 kg
  • Plazo de entrega: 3-5 business days for stock items
  • Documentación: Certificado de análisis (COA), ficha de datos de seguridad (MSDS) y ficha técnica del producto (TDS) disponibles previa solicitud

Preguntas frecuentes

What is the minimum order quantity (MOQ) for Dapoxetine?

Our MOQ is 1 kg. For larger quantities, please contact us for pricing and availability.

What is the delivery time?

For stock items, delivery is typically 3-5 business days after order confirmation.

Do you provide a Certificate of Analysis (COA) and samples?

Yes, we provide a COA for each batch. Samples are available upon request.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

send us your specification for a quotation.

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Room,5-0203, Unit 5, Beiyuanmen Street,Xi'an,Shaanxi,China

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